Health Research Regulations, Capacity and the Health Research Consent Declaration Committee

As a consequence of the Health Research Regulations 2018: -

1. Health Research which involves processing of personal data is defined in Irish law.


2. Explicit consent of the data subject for processing of personal data for the purposes of health research is mandatory.

-Explicit consent is a legal term related to processing of personal data. It differs from informed consent to take part in a research project, and there are specific conditions which need to be met under GDPR to achieve explicit consent. (These conditions are also what differentiates 'explicit consent' from consent to processing of personal data obtained under the 1995 Data Protection Directive - see Graphic drafted BH Ethics)

-Explicit consent is such that an adult needs to have 'capacity' to give it. Where an adult does not have capacity, no other adult can give 'explicit consent' on his/her behalf.


3. Where a research study proposes to involve adults who lack capacity to give explicit consent, an application to the Health Research Consent Declaration Committee or HRCDC (link to HRCDC website) applies.
   
   -This committee was set up in 2019 as a consequence of the Health Research Regulations 2018 and reviews research studies where explicit consent cannot be obtained.
   
   -It is not a research ethics committee, and hence, researchers apply to the HRCDC after having applied to a research ethics committee.

Amendments to the HRRs, Jan 2021 - Emergency Research Only

• On the 21st January 2021, amendments to the HRRs took effect. As a result, subject to conditions, emergency research in adults who lack capacity to give explicit consent no longer requires an application to the HRCDC.


• 'Explicit consent' for the processing of personal data is still required, but this can now be 'deferred' (in time) until the participant (who is availing of emergency treatment) regains capacity.


• Researchers must seek deferred consent as soon as possible once capacity regained, inform the participant orally and in writing as soon as possible, and advise them if their information has been shared with anyone etc. etc. Refer to guidance here (link to Department of Health website)


• A reminder that 'explicit consent' is a legal term related to the processing of personal data, and differs from informed consent to take part in research.